1. Field of the Invention
The present invention relates to a light-protective container assembly for a light-sensitive fluid and, particularly, is directed to an intravenous flexible bag having a light-protective sleeve connected thereto so as to inhibit or prevent degradation of a light-sensitive solution contained within the flexible bag.
2. Description of Related Art
A variety of fluids are sensitive to at least a certain amount of electromagnetic energy within certain wavelengths, such as within the spectrum of visible light. Upon extended exposure, these fluids, hereinafter referred to generally as light-sensitive fluids, are susceptible to a chemical or photo-chemical reaction often resulting in degradation of the fluid. Depending upon the fluid, such reactions can take place within a matter of minutes or hours, while other fluids may require days or weeks before such degradation occurs. Light-sensitive fluids can be protected against such reactions by using a container made of a suitable material capable of blocking the transmission of detrimental electromagnetic energy. For example, the use of an opaque material is often preferred to protect against visible light. Certain situations or applications, however, preclude the use of opaque materials because visual inspection of the fluid is required. One such situation involves the use of intravenous or I.V. systems.
Flexible Intravenous (I.V.) bags are commonly used to store and administer medical agents to patients. The I.V. bags can contain a variety of fluids, such as water or saline, containing therapeutic agents including nutritional supplements, diagnostic substances, therapeutic substances, pharmaceuticals, medicaments and other drugs. A problem with such agents is that many are sensitive to electromagnetic energy, and particularly to light. Exposing such agents to light may cause a chemical or photo-chemical response, which often results in a loss of paternity and other undesirable impurities. Depending on the agent, this degradation can occur within 20 minutes of exposure to light or the like.
Furthermore, I.V. bags are typically flexible and made from a translucent or see-through material to allow visual inspection. In use, a caregiver hangs the I.V. bag on a pole. A delivery tube extends from the bottom of the bag to a needle that is inserted into the patient. The agent then gradually flows into the patient""s body, usually over a 1- to 24-hour period. As such, the contents of the I.V. bag, as well as the I.V. bag itself, is potentially exposed to damaging amounts of light.
One way to prevent exposure of an agent to light would be to make the I.V. bag of an opaque material. However, there is a risk that the pigment or dye that constitutes the opaque material will leach from the bag and contaminate the fluid. This risk is especially significant if the agent in the I.V. bag is expected to have a long shelf life. Additionally, making the bag opaque prevents visual inspection of its contents. Visual inspection of the bag is beneficial both during the manufacturing process and during use to ensure that the fluid in the I.V. bag is clean and free of particulates and precipitates, and to verify the amount of fluid remaining within the reservoir.
Another way to prevent exposure of an agent to light is to enclose the I.V. bag in a sealed overwrap that is opaque. However, these overwraps generally are configured to be torn off and discarded when the I.V. bag is to be used. Thus, the bag and its contents are exposed to light during use.
To protect the fluid from light or similar electromagnetic energy, caregivers may cover the I.V. bag with a separate cover that is made of translucent material such as that available from Medipak of Winchester, VA. The use of such separate cover, however, involves an additional step in the administration of an agent. That is, when the overwrap has been torn from the I.V. bag, the translucent cover, if provided, must be removed from the overwrap and manually placed in proper position over the I.V. bag prior to administration. However, caregivers tend to use such separate covers inconsistently, while more often, the cover is merely discarded with the overwrap and not used at all. This failure can be detrimental to some fluids, especially those containing agents that react quickly to electromagnetic energy, such as light. Additionally, such covers generally are configured such that one size is intended to fit all applications. As a result, such covers tend to be ill fitting and allow ambient light to pass onto the I.V. bag.
Alternatively, caregivers may merely attempt to cover the I.V. bag with a towel, linen, or some other shroud. These make-shift shrouds commonly fail to completely shield the I.V. bag from light and often fall from the I.V. bag. Another problem is that these attempts to shroud the I.V. bag do not easily permit visual inspection of the I.V. bag and its contents. Typically, the caregiver must remove the shroud from the I.V. bag, which again exposes the agent to potentially harmful light. Each time that a caregiver removes such a cover or shroud, there is an increased likelihood that the I.V. bag will not be properly recovered and the agent will be exposed to damaging light. As such there remains a need for an improved light-protective container assembly, as well as a method of making the same.
The purpose and advantages of the present invention will be set forth in and apparent from the description that follows, as well as will be learned by practice of the invention. Additional advantages of the invention will be realized and attained by the methods and systems particularly pointed out in the written description and claims hereof, as well as from the appended drawings.
To achieve these and other advantages and in accordance with the purpose of the invention, as embodied and broadly described, the invention includes a light-protective container assembly for a light-sensitive fluid. The container assembly generally includes a translucent container, although more preferably transparent, and a flexible sleeve connected to the container. The container has an inner reservoir defined therein to contain the fluid. The sleeve, which is configured to substantially cover the container, is made of a material capable of substantially preventing the transmission of an identified range of wavelengths from the electromagnetic spectrum.
To connect the sleeve, the container preferably has at least one passageway defined therethrough, wherein the passageway is isolated from the inner reservoir. The sleeve has a first portion, which is positioned on one side of the container, and a second portion, which is positioned on an opposite side of the container. The first portion of the sleeve is attached to the second portion through the passageway to connect indirectly the sleeve to the container. Preferably, a plurality of passageways are provided, with the first and second portions of the sleeve being attached to each other through each passageway. Although a separate fastener, such as a snap, button, clip or adhesive, may be used, a heat stake or similar thermal weld is preferred.
The container is translucent, and more preferably transparent, to allow visual inspection selectively of the fluid contained therein and, in accordance with one aspect of the invention, the container is a flexible intravenous supply bag having a port structure at one end. As such, the sleeve is configured to extend at least over the reservoir of the container, and preferably over the port structure. Furthermore, and in accordance with a preferred embodiment, the first portion of the sleeve is a first side wall having opposite lateral edge portions, and the second portion of the sleeve is a second side wall having opposite lateral edge portions. In this manner, the lateral edge portions of the first side wall are integral with the lateral edge portions of the second side wall to define a tubular structure having at least one opened end to allow the sleeve to be displaced selectively for visual inspection of the container and the contents therein.
The sleeve is provided to prevent the transmission of electromagnetic energy having wavelengths that would be detrimental to the fluid to be contained within the container. Preferably, the identified range of wavelengths blocked by the sleeve is between about 190 nanometers to about 490 nanometers, and more preferably, the transmission is prevented of at least about 95% of the electromagnetic energy having wavelengths between about 290 nanometers to about 450 nanometers.
The present invention also includes a method of making a light-protective container assembly for a light-sensitive fluid. The method includes the step of identifying a range of wavelengths of the electromagnetic spectrum to which the light-sensitive fluid is susceptible to degradation. A translucent container having an inner reservoir therein, such as an intravenous bag, is provided to contain the light-sensitive fluid. The method further includes the steps of producing a flexible sleeve made of a material capable of substantially preventing the transmission of the identified range of wavelengths of the electromagnetic spectrum, wherein the sleeve is configured to cover the container, and then connecting the sleeve to the container.
To produce the sleeve, the method preferably includes preparing a mixture of a base material for the sleeve and a colorant capable of substantially preventing the transmission of the identified range of wavelengths of the electromagnetic spectrum through a predetermined thickness of the base material. For example, and with regard to the sleeve embodied herein, a pigment formulation is used including a sufficient amount of yellow pigment formulated 5 to prevent the transmission of at least about 95% of electromagnetic energy having a wavelength between about 290 nanometers to about 450 nanometers through the predetermined thickness of the base material. The mixture is then formed into the sleeve, preferably so as to have a tubular configuration with side walls of the predetermined thickness.
In a preferred embodiment, the sleeve is connected indirectly to the container by including at least one passageway through the container, wherein the passageway is isolated from the inner reservoir. The sleeve is positioned on the container with one portion of the sleeve on one side of the container and another portion on an opposite side of the container. The first and second portions are then attached together, such as by a heat stake or a fastener, through the passageway to connect indirectly the sleeve to the container.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the invention claimed.
The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the method and system of the invention. Together with the description, the drawing serves to explain the principles of the invention.